House Melendez posted an update 2 years, 4 months ago
Phase II can include pharmacokinetics and dosing in patients, and Phase III is a very large study of efficacy in the intended patient population. This process generally involves submission of an Investigational New Drug filing with sufficient pre-clinical data to support proceeding with human trials. In the United States, new pharmaceutical products must be approved by the Food and Drug Administration (FDA) as being both safe and effective.
Lecture scripts and even journal articles presented by academic researchers may actually be "ghost-written" by pharmaceutical companies. Sponsored researchers are rewarded by drug companies, for example with support for their conference/symposium costs. 79 Some approved drugs, such as those based on re-formulation of an existing active ingredient (also referred to as Line-extensions) are much less expensive to develop.
Some of these estimates also take into account the opportunity cost of investing capital many years before revenues are realized (see Time-value of money ). Because of the very long time needed for discovery, development, and approval of pharmaceuticals, these costs can accumulate to nearly half the total expense. 77 According to Forbes, by 2010 development costs were between $4 billion to $11 billion per drug. More recently, multi-nationals are increasingly relying on contract research organizations to manage drug development.
Drug development refers to activities undertaken after a compound is identified as a potential drug in order to establish its suitability as a medication. In the past most drugs have been discovered either by isolating the active ingredient from traditional remedies or by serendipitous discovery. Drug discovery is the process by which potential drugs are discovered or designed.
After five years, the study concluded the patients saw a 35% reduction in their cholesterol, and their chances of dying of a heart attack were reduced by 42%. In 1971, Akira Endo, a Japanese biochemist working for the pharmaceutical company Sankyo, identified mevastatin (ML-236B), a molecule produced by the fungus Penicillium citrinum, as an inhibitor of HMG-CoA reductase, a critical enzyme used by the body to produce cholesterol. The firm continued to pressure Kelsey and the FDA to approve the application until November 1961, when the drug was pulled off the German market because of its association with grave congenital abnormalities.
The FDA medical officer in charge of reviewing the compound, Frances Kelsey , believed that the data supporting the safety of thalidomide was incomplete. 52 This development was associated with a substantial decline in the mortality rate among people with hypertension. Early developments in the field of treating hypertension included quaternary ammonium ion sympathetic nervous system blocking agents, but these compounds were never widely used due to their severe side effects, because the long term health consequences of high blood pressure had not yet been established, and because they had to be administered by injection.